Anatomical and functional clinical research
The Casey Reading Center (CRC) is a team of physicians, scientists and staff who are focused on partnering with sponsors to ensure the highest level of quality and insight is derived from clinical trials. Since our initial inception in 2009 we have developed FDA-compliant standard operating procedures and quality assurance measures determined to be "best in class" by external auditors. This quality allows us to offer the most sophisticated analysis platforms available in ophthalmic imaging and functional assessment.
The Casey Reading Center combines its’ 30+ years of experience with perimetry to determine the appropriate standards by which sites participating in clinical trials may demonstrate their proficiency, and advanced volumetric analyses of trial results.
The CRC has worked with Sponsors and in close collaboration with the COOL lab to develop and perform advanced OCT and OCTA analyses for a wide variety of disease applications to gain insight into precise anatomical biomarkers of retinal disease.
Clinical trial design and Endpoint development
Development of clinical site manual of procedures
Certification of clinical sites
Internal validation of key grading criteria across modalities
Clinical site support
Real-time sponsor and CRO access to clinical trial reads and reports
Sponsor-tailored data outputs
Infrastructure - security, database input/output
Data infrastructure and security
The CRC offers interactive and secure web-based software for the management of clinical trials. It is remotely accessible, allowing easy upload of data and image files from clinical sites while allowing real time access for the CRC, sponsors and clinical research organizations. Due to its accessibility, we have taken great pains to ensure the data housed within our database is electronically secured. The reading center software, database and server are FDA compliant for electronic records, according to 21 CFR Part 11, and we follow the FDA guidance put forth on General Principles of Software Validation; Final Guidance for Industry and FDA Staff. The data center and servers are maintained by a specialized team of information technology professionals. Data is backed-up daily and stored off-site. Servers are protected by SSL encryption, ongoing virus and malware surveillance, as well as scanning at the time of upload.
Ongoing and final reports
We provide real-time assessment of data quality for sponsors to access as well as quarterly reports. Flags for poor data are generated for sponsors and for clinical sites and remedial actions are planned if necessary. The CRC provides endpoint exports in XML format. The sponsor can develop an automated import of the XML file for data analysis for timely review at scientific conferences or Data and Safety Monitoring Boards.
The Casey Reading Center offers a full-service experience, and sponsors can choose which options will meet their goals. We offer study consultation on clinical trial design and endpoint determination for each of the modalities that we offer, trial certification, assessment of anatomical and functional clinical trial endpoints. In addition, we offer post-hoc research into the data to investigate signals that may have arisen during the trial or found from new developments in the field.
We look forward to working with sponsors from the inception of a clinical trial through its conclusion to provide the best experience possible in obtaining verified data.